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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213983
Company: VIIV HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIVICAY PD DOLUTEGRAVIR SODIUM EQ 5MG BASE TABLET, FOR SUSPENSION;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/12/2020 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213983s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213983Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213983Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/09/2021 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204790s028,213983s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204790Orig1s028; 213983Orig1s002ltr.pdf
03/23/2021 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204790s029,213983s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204790Orig1s029,213983Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/09/2021 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204790s028,213983s002lbl.pdf
03/23/2021 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204790s029,213983s001lbl.pdf
03/23/2021 SUPPL-1 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204790s029,213983s001lbl.pdf
06/12/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213983s000lbl.pdf
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